BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LYNX SYSTEM

    MDR report key: 3243482 · Received July 23, 2013

    Report

    Report Number
    3005099803-2013-07663
    Event Type
    Injury
    Date Received
    July 23, 2013
    Report Date
    June 26, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013 STATED THAT ALTHOUGH THE DATE OF BIRTH IS UNKNOWN; THE PATIENT WAS REPORTED TO BE OVER 18 YEARS OLD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LYNX SUPRAPUBIC MID-URETHRAL SLING SYSTEM WAS IMPLANTED (B)(6) 2007. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED AN UNKNOWN INJURY. ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN'S OFFICE ON (B)(6) 2013, STATED THAT THE PATIENT WAS RELEASED AFTER SURGERY WITH NO COMPLICATIONS AND WAS LAST SEEN ON (B)(6) 2011 FOR A PAP SMEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343292 LYNX SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH UNK564

    Patients

    Seq Age Sex Outcome Treatment
    1 Other